Trial Radar IA
Lo studio clinico NCT07469592 per Trapianto di cellule staminali, Sindrome mielodisplastica, Leucemia Mieloide Acuta, Leucemia-linfoma linfoblastica delle cellule precursori, Linfoma non-Hodgkin è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation 165

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07469592 è uno studio interventistico per Trapianto di cellule staminali, Sindrome mielodisplastica, Leucemia Mieloide Acuta, Leucemia-linfoma linfoblastica delle cellule precursori, Linfoma non-Hodgkin, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 30 aprile 2026, con l'obiettivo di raggiungere 165 partecipanti. Sotto la guida di l'Università di Miami, dovrebbe concludersi entro il 30 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 marzo 2026.
Sommario breve
The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.
Titolo ufficiale

eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation

Patologie
Trapianto di cellule staminaliSindrome mielodisplasticaLeucemia Mieloide AcutaLeucemia-linfoma linfoblastica delle cellule precursoriLinfoma non-Hodgkin
Altri ID dello studio
Numero NCT
Data di inizio (effettiva)
2026-04-30
Ultimo aggiornamento pubblicato
2026-03-13
Data di completamento (stimata)
2028-06-30
Arruolamento (previsto)
165
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Scopo principale
Terapia di supporto
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleeHealth Mindfulness-based Music Therapy (eMBMT)
Participants will be in the MBMT group for 5 months.
eHealth Mindfulness-based Music Therapy (eMBMT)
Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
SperimentaleeHealth Mindfulness Meditation (eMM)
Participants will be in the MM group for 5 months.
eHealth Mindfulness Meditation (eMM)
Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)
Health Related Quality of Life will be measured using the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), a validated 47-item patient-reported outcome measure. It includes the FACT-G core questionnaire (Physical, Social/Family, Emotional, and Functional Well-Being) plus a Bone Marrow Transplant Subscale. Each item is rated on a 5-point Likert scale (0 = not at all; 4 = very much). Subscale scores are summed up to produce a total score, with higher scores indicating better quality of life. Change from baseline will be analyzed using mixed-effects models adjusted for baseline score. FACT-BMT total score (range: 0 to 176)
Baseline (T1), up to 18 months
Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.
Baseline (T1), up to 18 months
Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.
Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).
The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.
Baseline (T1), up to 18 months
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.
Baseline (T1), up to 18 months
Number of Days to Engraftment Measured from Infusion to Engraftment.
To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.
Up to 18 months
Number of Days of Hospitalization Measured from Admission to Engraftment.
To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.
Up to 18 months
Number of Hospital Readmissions after Hospital Discharge
To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.
Up to 100 days
Number of Infections from Hospital Admission
To measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.
up to 100 Days Post-Infusion Day
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.
Baseline (T1), up to 18 months
Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).
GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.
Baseline (T1), up to 18 months
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.
Baseline (T1), up to 18 months
Change in Serum Cortisol as Measured by ELISA
Serum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation
Baseline (T1), up to 18 months
Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay
Cytokines levels are measured in pg/mL. Plasma concentrations of 10 cytokines (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α) are measured via the Novex Life Technologies Human Cytokine 10-Plex Kit on the Magpix Luminex platform (ThermoFisher). Assay sensitivity is 0.5-5 pg/mL per analyte with a \>3-log dynamic range. Elevated pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α) and suppressed anti-inflammatory cytokines (e.g., IL-10) are associated with immune dysregulation and chronic stress.
Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Thymic Function
Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Regulatory T cells
Regulatory T cells measured as cells/mm\^3
Baseline (T1), up to 18 months
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • ≥ 18 years of age
  • have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome \[MDS\], acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], or non Hodgkin's Lymphoma \[NHL\])
  • have a treatment plan for a hematopoietic stem cell transplant
  • Speak English or Spanish

  • history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)
  • severe cognitive impairment (per the short portable mental status questionnaire)
  • hearing impairment
  • active alcohol or substance dependence within the past six months
  • participated in the prior pilot MBMT R61 phase
  • participated in music therapy or mindfulness programs in the past six months
National Cancer Institute (NCI) logoIstituto nazionale dei tumori, Estados Unidos
Parte responsabile dello studio
Frank Penedo, Investigatore principale, Professor, University of Miami
Contatti principali dello studio
Contatto: Frank J Penedo, PhD, (305) 284-4290, [email protected]
Contatto: Sara E Fleszar-Pavlovic, PhD, (305) 243-4009, [email protected]
1 Centri dello studio in 1 paesi

Florida

University of Miami, Miami, Florida, 33136, United States
Juan Caffroni, Contatto, 305-243-4445, [email protected]
Frank J Penedo, PhD, Investigatore principale